Overview

Dopaminergic Therapy for Frontotemporal Dementia Patients

Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.
Phase:
Phase 2
Details
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Collaborator:
Alzheimer's Drug Discovery Foundation
Treatments:
Rotigotine